Devices, methods, and kits for forming tracts in tissue

Abstract

Tissue tract-forming devices, methods, and kits are disclosed. In some variations, a method for forming a tract in a tissue wall having an interior surface and an exterior surface may comprise advancing an anchor member through the tissue wall and into a lumen defined by the tissue wall, the anchor member comprising a proximal portion, a distal portion, and an intermediate portion therebetween, wherein the proximal and intermediate portions are angled with respect to each other and the intermediate and distal portions are angled with respect to each other, positioning the anchor member so that the intermediate portion contacts the interior surface of the tissue wall and the distal portion is angled toward the interior surface of the tissue wall, and advancing a tissue-piercing member into the tissue wall while the intermediate portion is in contact with the interior surface of the tissue wall, to form a tract in the tissue wall.

1 . A method for forming a tract in a tissue wall having an interior surface and an exterior surface, the method comprising:
 advancing an anchor member through the tissue wall and into a lumen defined by the tissue wall, the anchor member comprising a proximal portion, a distal portion, and an intermediate portion therebetween, wherein the proximal and intermediate portions are angled with respect to each other and the intermediate and distal portions are angled with respect to each other;   positioning the anchor member so that the intermediate portion contacts the interior surface of the tissue wall and the distal portion is angled toward the interior surface of the tissue wall; and   advancing a tissue-piercing member into the tissue wall while the intermediate portion is in contact with the interior surface of the tissue wall, to form a tract in the tissue wall.   
     
     
         2 . The method of  claim 1 , wherein the distal portion of the anchor member lifts a portion of the tissue wall when the intermediate portion of the anchor member is in contact with the interior surface of the tissue wall. 
     
     
         3 . The method of  claim 1 , wherein the method comprises using the anchor member to stabilize the tissue wall prior to advancement of the tissue-piercing member into the tissue wall. 
     
     
         4 . A device for forming a tract in tissue comprising:
 a guide;   a tissue-piercing member slidably housed within the guide and deployable from the guide through an opening in the guide; and   an anchor member coupled to or integral with the guide, the anchor member comprising a first elongated portion, a second elongated portion that is angled with respect to the first elongated portion, and a third elongated portion that is angled with respect to the second elongated portion,   wherein the first elongated portion defines a first plane and the second elongated portion defines a second plane, and wherein the first and second planes have a first angle of about 1° to about 175° therebetween.   
     
     
         5 . The device of  claim 4 , wherein the first angle is about 5° to about 30°. 
     
     
         6 . The device of  claim 4 , wherein the first angle is about 5° to about 20°. 
     
     
         7 . The device of  claim 4 , wherein the first angle is about 5° to about 15°. 
     
     
         8 . The device of  claim 4 , wherein the first angle is about 12°. 
     
     
         9 . The device of  claim 4 , wherein the first angle is about 5° to about 10°. 
     
     
         10 . The device of  claim 4 , wherein the first elongated portion has a length of about 2 millimeters to about 6 millimeters. 
     
     
         11 . The device of  claim 10 , wherein the first elongated portion has a length of about 4 millimeters. 
     
     
         12 . The device of  claim 4 , wherein the tissue-piercing member has a first longitudinal axis and the third elongated portion has a second longitudinal axis that forms a second angle of about 6° to about 30° with the first longitudinal axis upon deployment of the tissue-piercing member from the guide. 
     
     
         13 . The device of  claim 4 , wherein the tissue-piercing member comprises a needle. 
     
     
         14 . The device of  claim 13 , wherein the needle is hollow. 
     
     
         15 . The device of  claim 4 , wherein the third elongated portion defines a third plane, and wherein the second and third planes have a second angle of about 6° to about 25° therebetween. 
     
     
         16 . The device of  claim 15 , wherein the second angle is from about 10° to about 20°. 
     
     
         17 . The device of  claim 4 , wherein the anchor member extends distally from the guide. 
     
     
         18 . A device for forming a tract in tissue comprising:
 a guide;   a tissue-piercing member slidably housed within the guide and deployable from the guide through an opening in the guide; and   an anchor member coupled to or integral with the guide, the anchor member comprising first, second, and third elongated portions, a first curved portion between the first and second elongated portions, and a second curved portion between the second and third elongated portions,   wherein the first curved portion defines a first plane and the second curved portion defines a second plane that is angled with respect to the first plane.   
     
     
         19 . The device of  claim 18 , wherein the first and second planes have an angle of about 1° to about 175° therebetween. 
     
     
         20 . The device of  claim 18 , wherein the first curved portion has a radius of curvature of about 0.1 millimeter to about 2 millimeters. 
     
     
         21 . The device of  claim 20 , wherein the second curved portion has a radius of curvature of about 0.1 millimeter to about 2 millimeters. 
     
     
         22 . The device of  claim 18 , wherein the anchor member is flexible. 
     
     
         23 . The device of  claim 18 , wherein the anchor member further comprises a guide eye sheath. 
     
     
         24 . The device of  claim 18 , wherein the anchor member further comprises an attachable guidewire. 
     
     
         25 . The device of  claim 18 , wherein the tissue-piercing member comprises a needle. 
     
     
         26 . The device of  claim 25 , wherein the needle is hollow. 
     
     
         27 . The device of  claim 18 , wherein the opening in the guide is located proximal to a distal end of the anchor member. 
     
     
         28 . A method for forming a tract in a tissue wall having an interior surface and an exterior surface, the method comprising:
 advancing an anchor member through the tissue wall, the anchor member comprising first, second, and third elongated portions, a first curved portion between the first and second elongated portions, and a second curved portion between the second and third elongated portions, the first curved portion defining a first plane and the second curved portion defining a second plane that is angled with respect to the first plane;   contacting the anchor member with the interior surface of the tissue wall; and   advancing a tissue-piercing member into the tissue wall while the anchor member is in contact with the interior surface of the tissue wall, to form a tract in the tissue wall.   
     
     
         29 . The method of  claim 28 , wherein the tissue comprises a vessel and the method comprises advancing the anchor member into a lumen of the vessel. 
     
     
         30 . The method of  claim 29 , wherein the vessel comprises an artery. 
     
     
         31 . The method of  claim 28 , wherein the tissue-piercing member has a first longitudinal axis and the third elongated portion of the anchor member has a second longitudinal axis, and the first and second longitudinal axes form an angle therebetween. 
     
     
         32 . The method of  claim 31 , wherein the angle between the first and second longitudinal axes is from about 6° to about 30° when the tissue-piercing member is advanced through the tissue wall. 
     
     
         33 . The method of  claim 31 , further comprising advancing the tissue-piercing member into a lumen defined by the tissue wall, wherein the angle between the first and second longitudinal axes is from about 6° to about 30° upon entry of the tissue-piercing member into the lumen. 
     
     
         34 . A device for forming a tract through tissue comprising:
 a guide;   an anchor member coupled to or integral with a distal portion of the guide;   a marker port coupled to or integral with a proximal portion of the guide and having a first lumen;   a tissue-piercing member deployable from the guide; and   a pushing member configured to deploy the tissue-piercing member from the guide,   wherein the tissue-piercing member comprises a first tubular member comprising a wall portion having a plurality of apertures therethrough, such that the tissue-piercing member is in fluid communication with the marker port.   
     
     
         35 . The device of  claim 34 , wherein the tissue-piercing member remains in fluid communication with the marker port when translated by the pushing member. 
     
     
         36 . A device for forming a tract through tissue comprising:
 a marker port comprising a lumen; and   a tissue-piercing member comprising a tubular member comprising a wall portion having a plurality of apertures therethrough,   wherein at least a portion of the tissue-piercing member passes through the lumen of the marker port.   
     
     
         37 . A method of forming a tract through tissue using a device comprising an anchor member, a marker port, and a tissue-piercing member at least partially disposed within the marker port and comprising a tubular member comprising a wall portion having a plurality of apertures therethrough, the method comprising:
 advancing the anchor member into a vessel wall defining a first lumen until blood flows through the marker port to indicate that the anchor member has entered the first lumen; and   advancing the tissue-piercing member into the vessel wall while the anchor member is disposed within the first lumen.   
     
     
         38 . The method of  claim 37 , wherein the tissue-piercing member comprises a second lumen and wherein the method further comprises advancing a guidewire through the second lumen. 
     
     
         39 . The method of  claim 37 , wherein the tissue-piercing member is advanced into the vessel wall by pushing on a pushing member that is in contact with the tissue-piercing member. 
     
     
         40 . A device for forming a tract through tissue comprising:
 a guide;   a tissue-piercing member deployable from the guide;   an anchor member coupled to or integral with the guide; and   a sheath coupled to the anchor member,   wherein the sheath comprises a flexible elongated member comprising a distal portion comprising a first region having a first cross-sectional diameter and a second region that is integral with the first region, the second region having a second cross-sectional diameter that is different from the first cross-sectional diameter.   
     
     
         41 . A method of making a device for forming a tract through tissue comprising:
 forming a sheath using a bump extrusion process; and   coupling the sheath to an anchor member that is coupled to or integral with a guide configured for deployment of a tissue-piercing member therefrom.   
     
     
         42 . The method of  claim 41 , wherein the guide comprises a lumen and a tissue-piercing member slidably disposed within the lumen. 
     
     
         43 . A system for forming a tract through tissue comprising:
 a device comprising a guide, an anchor member coupled to or integral with the guide, a pushing member, and a tissue-piercing member deployable from the guide by pushing on the pushing member; and   a syringe,   wherein the pushing member comprises an elongated member having a handle portion at its proximal end, and wherein the syringe is configured to couple with the handle portion.   
     
     
         44 . The system of  claim 43 , wherein the handle portion of the pushing member comprises a female connector and the syringe comprises a male connector configured to couple to the female connector. 
     
     
         45 . A device for forming a tract in tissue comprising:
 a guide;   a tissue-piercing member slidably housed within the guide and deployable through an opening in the guide;   an anchor member coupled to or integral with the guide;   a retainer configured to be actuated from a position in which the retainer is aligned with the anchor member to a position in which the retainer extends from the anchor member; and   a tensioning apparatus comprising a tensioning member configured to actuate the retainer, and a tubular member housing a portion of the tensioning member, wherein the tubular member is coupled to or integral with the guide.   
     
     
         46 . The device of  claim 45 , wherein the tensioning member is coupled to the retainer. 
     
     
         47 . A device for forming a tract in tissue comprising:
 a guide;   a tissue-piercing member slidably housed within the guide and deployable through an opening in the guide;   an anchor member coupled to or integral with the guide;   a retainer configured to be actuated from a position in which the retainer is aligned with the anchor member to a position in which the retainer extends from the anchor member; and   a tensioning apparatus comprising a tensioning member configured to actuate the retainer and a semitubular member housing a portion of the tensioning member,   wherein the semitubular member is coupled to or integral with the guide.   
     
     
         48 . The device of  claim 47 , wherein the tensioning member is coupled to the retainer. 
     
     
         49 . A device for forming a tract in tissue comprising:
 a guide;   a tissue-piercing member slidably housed within the guide and deployable through an opening in the guide;   an anchor member coupled to or integral with the guide;   a retainer configured to be actuated from a position in which the retainer is aligned with the anchor member to a position in which the retainer extends from the anchor member; and   a tensioning member coupled to the retainer and configured to actuate the retainer,   wherein a first portion of the tensioning member is disposed along an outer surface of the guide, a second portion of the tensioning member passes through an opening in a wall portion of the guide, and a third portion of the tensioning member is disposed within a lumen of the guide.   
     
     
         50 . The device of  claim 49 , wherein the portion of the guide housing the tensioning member has a non-circular cross-section. 
     
     
         51 . The device of  claim 50 , wherein the portion of the guide housing the tensioning member has an elliptical cross-section. 
     
     
         52 . The device of  claim 49 , wherein the portion of the guide housing the tensioning member is sized and shaped to house both the tensioning member and the tissue-piercing member.